The Need for Rehabilitation and the Connection With Attachment Styles Among Patients With Gynaecological Cancer

Depression Clinical Trial

Official title:

Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01638741
• Other study ID #: Rehabilitation
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2012
• Last updated: April 23, 2013
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: April 2013
• Source: Odense University Hospital
• Contact: Kamila A. Holt, Ph.D. student
• Phone: 0045 26 82 26 57
• Email: kamila.holt[@]rsyd.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to provide new knowledge about:

• Integration of rehabilitation in a highly specialized gynaecological department.

• Development and testing of an individually adapted rehabilitation process.

• Needs for rehabilitation among women with gynaecological cancer.

• Connection between adult attachment style for women with gynaecological cancer and their quality of life, rehabilitation needs and symptoms of depression /PTSD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• suspicion of gynaecological cancer

• surgery for gynaecological cancer

Exclusion Criteria:

• do not speak Danish

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult Attachment Style
• Depression
• Needs for Rehabilitation
• PTSD
• Quality of Life.

Intervention

Behavioral:
• Rehabilitation goals of patients with gynaecological cancer.
Conversations with the nurse and supportive phone calls. Conversation are structured and placed 1 and 3 months after surgery. Phone calls are carried out at two and three months after surgery.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Fyn

Sponsors (3)

Lead Sponsor	Collaborator
Kamila Adellund Holt	Odense University Hospital, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Quality of life at 5 months after surgery.	EORCT QLQ-C 30 (QLQ is quality of life questionnaire) and EORCT QLQ-OV28 (OV - Ovarian) and EORCT QLQ-EN ( EN - endometrial) 24 and EORCT QLQ- CX 24 ( CX - cervix.	at baseline and 5 months after surgery	No
Secondary	Change from baseline in Revised Adult Attachment at 5 months after surgery.	Revised Adult Attachment Scale (RAAS- 18) is used to measure attachment style among women with gynaecological cancer.	At baseline and 5 months after sugery	No
Secondary	Change from baseline in Depression at 5 months after surgery.	MDI-12 (Major Depression Inventory), ICD-10 (International Classification of Diseases), measure the depression level in the period from baseline and 5 months after surgery.	At baseline and 5 months after surgery.	No
Secondary	Change from baseline in Posttraumatic stress disorder at 5 months after surgery	To measure the Posttraumatic stress disorder we uge HTQ-17 (Harvard Trauma Questionnaire) for PTSD (Post Traumatic Stress Disorder).	At baseline and 5 months after surgery.	No